Archive | Regulatory

NICE green light for Keytruda in melanoma setting

Source: Pharma Times, January 2019 The guidelines apply to adults who have disease that has spread to the lymph nodes and who have already had surgery to remove the tumour and associated lymph glands. Keytruda (pembrolizumab) is a type of immunotherapy that works by boosting the body’s natural defences to fight cancer. In this setting, […]

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Posted in Melanoma News, Regulatory, Publications

FDA approves ‘precision medicine’ drug for different cancers with same mutation

Source: The Washington Post, January 2019 The Food and Drug Administration on Monday approved a drug for a wide range of cancers based on a shared mutation, rather than the tumors’ locations — an advance for the sometimes controversial field of “precision medicine.” The medication, called Vitrakvi, is the second treatment to receive FDA clearance […]

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Posted in Melanoma News, Regulatory, Publications

CHMP Favors EU Approval of Keytruda for Advanced Melanoma Patients with Complete Tumor Resection

Source: Immuno-oncology News, December 2018 The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Keytruda(pembrolizumab) for the treatment of advanced melanoma patients whose tumor has been completely removed in surgery. The European Commission will now review CHMP’s opinion before making a final decision regarding […]

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BRIEF—Health Canada added approval for Tafinlar plus Mekinist combo

Source: The Pharma Letter, December 2018 Pharma regulator Health Canada has approved the use of a combination of two Novartis cancer therapies as targeted treatment to prevent recurrence of melanoma following surgery, also referred to as adjuvant treatment. The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) has been approved for the adjuvant treatment of patients […]

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Posted in Melanoma News, Regulatory, Publications